Apparatus and method for promoting angiogenesis in ischemic tissue

Abstract

A biologics delivery device and method of use for promoting angiogenesis in occluded vessels and ischemic tissue of a patient are provided, wherein the biologics delivery device includes a catheter having a proximal end, a distal region having a distal end, and a side wall defining a catheter lumen; an expandable member disposed in the distal region, the expandable member configured to support a subintimal space in an occluded blood vessel of a patient, and to transition between a collapsed state and an expanded state; and a hollow needle having a penetration tip deployable from inside the catheter lumen to outside the catheter lumen, and into tissue surrounding the occluded blood vessel, wherein the expandable member in the expanded state allows the flow of oxygenated blood to the occluded blood vessel. Methods of using the inventive biologics delivery device also are provided to deposit the biologic from a subintimal space to tissue surrounding the occluded blood vessel.

What is claimed is: 
     
       1. A method of promoting angiogenesis in an ischemic area of a patient body, comprising:
 accessing a subintimal space between an adventitial layer and an intimal layer of a vascular wall of an occluded blood vessel, the subintimal space having a surface; 
 providing a biologics delivery device comprising a catheter having a proximal end, a distal region having a distal end, a side wall defining a catheter lumen, an expandable member configured to transition between a collapsed state and an expanded state, and a retractably deployable hollow needle within the catheter lumen, the hollow needle having a penetration tip and a biologics delivery lumen extending therethrough; 
 introducing the distal end of the biologics delivery device into the subintimal space; 
 transitioning the expandable member positioned in the subintimal space to an expanded state to contact and support the surface of the subintimal space; 
 deploying the penetration tip of the needle from inside the catheter lumen to outside the catheter lumen, through the expandable member, and into tissue surrounding the occluded blood vessel; and 
 delivering a biologic through the biologics delivery lumen to the tissue. 
 
     
     
       2. The method of  claim 1 , wherein deploying the penetration tip of the hollow needle comprises deploying the penetration tip of the hollow needle from a side opening formed through the side wall of the catheter. 
     
     
       3. The method of  claim 1 , wherein the expandable member comprises a plurality of strands, and wherein transitioning the expandable member to the expanded state comprises compressing the plurality of strands until the plurality of strands expands radially outward. 
     
     
       4. The method of  claim 1 , wherein transitioning the expandable member to the expanded state comprises retracting a sheath slidably receiving the expandable member. 
     
     
       5. The method of  claim 1 , wherein the expandable member comprises a plurality of mesh cells. 
     
     
       6. The method of  claim 1 , wherein deploying the penetration tip of the hollow needle comprises deploying the penetration tip of the hollow needle through the expandable member in the expanded state. 
     
     
       7. The method of  claim 1 , wherein deploying the penetration tip of the hollow needle comprises deploying a nitinol needle. 
     
     
       8. The method of  claim 1 , further comprising determining the deployment of the hollow needle using at least one radiopaque mark disposed on the biologics delivery device. 
     
     
       9. The method of  claim 1 , wherein the biologic comprises one or more hematopoietic stem cells, endothelial progenitor cells, mesenchymal stem cells, embryonic stem cells, induced pluripotent stem cells, growth factors, or any combination thereof.